Catheter shaft junction having a polymeric multilayered sleeve with a low processing temperature outer layer

ABSTRACT

One aspect of the invention is directed to a balloon catheter with a multilayered polymeric sleeve at the rapid exchange intermediate section, having an outer layer formed of a polymer with a relatively low processing temperature (i.e., melting temperature for semi-crystalline polymers or glass transition temperature for amorphous polymers), and having an inner layer.

CROSS-REFERENCES TO RELATED APPLICATIONS

This Application is a continuation-in-part of application Ser. No.10/010,212, filed Dec. 4, 2001, incorporated by reference herein in itsentirety.

BACKGROUND OF THE INVENTION

This invention relates generally to catheters, and particularly tointravascular catheters for use in percutaneous transluminal coronaryangioplasty (PTCA), or the delivery of stents.

In a typical PTCA procedure, a dilatation balloon catheter is advancedover a guidewire to a desired location within the patient's coronaryanatomy to position the balloon of the dilatation catheter along thestenosis to be dilated. The balloon is then inflated one or more timeswith fluid at relatively high pressures (generally 4-16 atmospheres) todilate the stenosed region of the diseased artery. A stent is commonlyimplanted within the artery, typically by delivery to the desiredlocation within the artery in a contracted condition on a balloon of acatheter which is similar in many respects to a balloon angioplastycatheter. Inflation of the balloon expands the stent, thereby implantingit in the artery. Following the dilatation or stent expansion, theballoon is deflated and the catheter repositioned or withdrawn from theartery.

In rapid exchange type balloon catheters, the catheter has an inflationlumen extending from the proximal end of the catheter to a balloon on adistal shaft section, a distal guidewire port at the distal end of thecatheter, a proximal guidewire port located distal to the proximal endof the catheter, and a relatively short guidewire lumen extendingtherebetween. The rapid exchange junction located at the proximalguidewire port should provide a good transition in flexibility from therelatively stiff proximal shaft section to the relatively flexibledistal shaft section. One difficulty has been forming a junction whichis flexible, yet kink resistant and rugged.

To help meet the desire for a catheter having sufficient pushability andcrossability, while maintaining trackability within the patient'stortuous vasculature, prior art designs have supplemented polymercatheter shafts with a support mandrel. Other prior art designs haveaddressed these handling and performance issues by using materials ofdifferent stiffness for the proximal and distal portions of thecatheter, and employing a high strength metallic proximal shaft section,commonly called a hypotube. To prevent kinking at the junction of thesetwo materials, while maintaining trackability, some conventional designshave employed reinforcing layers or stiffening wires to bridge thetransition in catheter shaft material. Despite these attempts, prior artdesigns have suffered from various drawbacks relating to these handlingand performance issues.

Accordingly, it would be a significant advance to provide a catheterhaving an improved catheter shaft junction between shaft sections suchas the proximal and distal shaft sections. This invention satisfiesthese and other needs.

SUMMARY OF THE INVENTION

The invention is generally directed to a balloon catheter having apolymeric reinforcing member or multilayered sleeve at a junctionbetween shaft sections such as the junction between the proximal shaftsection and the distal shaft section. In a presently preferredembodiment, the balloon catheter is a rapid exchange type catheter. Thepolymeric reinforcing member is around or within either or both of thetubular member defining the inflation lumen or the tubular memberdefining the guidewire lumen at the rapid exchange junction. In anotherembodiment, the balloon catheter has a multilayered polymeric sleeve atthe rapid exchange intermediate section, having an outer layer formed ofa polymer having a relatively low glass transition temperature ormelting temperature, and an inner layer. The reinforcing tubular memberor the multilayered polymeric sleeve at the rapid exchange junction ofthe shaft prevents or inhibits damage to the tubular members definingthe inflation lumen and/or guidewire lumen during assembly or use of thecatheter, and thus avoids a loss of lumen integrity.

The balloon catheter of the invention generally comprises an elongatedshaft having a proximal shaft section, a distal shaft section, aninflation lumen, a guidewire receiving lumen extending within at leastthe distal shaft section, and a balloon on the distal shaft section withan interior in fluid communication with the inflation lumen. The shaftproximal shaft section comprises a proximal tubular member having aproximal end, a distal end, a distal portion, and defining a proximalportion of the inflation lumen. The shaft distal shaft section comprisesan outer tubular member and an inner tubular member within the outertubular member lumen. The outer tubular member defines a distal portionof the inflation lumen, and the inner tubular member defines theguidewire receiving lumen in fluid communication with a guidewire distalport at the distal end of the catheter shaft, and a guidewire proximalport at the proximal end of the inner tubular member. As a rapidexchange type catheter, the proximal guidewire port at the rapidexchange junction is located at the proximal end of the distal shaftsection, distal to the proximal end of the catheter shaft. The innertubular member has a proximal portion generally in a side-by-siderelationship with the distal portion of the proximal tubular member. Thepolymeric reinforcing member is located around or within the proximalportion of the inner tubular member or the distal portion of theproximal tubular member.

The polymeric reinforcing member is preferably a tube having a shapeconfigured to correspond to the shape of the proximal portion of theinner tubular member or the distal portion of the proximal tubularmember, such as a circular, oblong/oval, D-shaped or C-shaped transversecross section. However, a variety of suitable shapes may be useddepending on the shape of the inner tubular member and the proximaltubular member. In a presently preferred embodiment, the polymericreinforcing member is formed of a first polymeric material having aglass transition temperature greater than a glass transition temperatureof a second polymeric material forming the distal portion of theproximal tubular member or the proximal portion of the inner tubularmember. The first polymeric material forming the polymeric reinforcingmember is preferably a high temperature, high modulus material, having aglass transition temperature (Tg) of about 300° C. to about 450° C., anda tensile modulus, expressed as a secant modulus (ASTM D882) of about350,000 to about 450,000 psi. In one embodiment, the first polymericmaterial forming the polymeric reinforcing member is selected from thegroup consisting of thermoset polyimide and thermoplastic polyimide. Thethermoset or thermoplastic polyimide has a high secant modulus ofgreater than about 350,000 psi, with about 25,000 to about 30,000 psitensile strength, which allows for a thin-walled reinforcing tube whichnonetheless has a sufficient strength to provide the requiredreinforcement. In a presently preferred embodiment, thermoset polyimideis used, due to the high glass transition temperature of the thermosetpolyimide. The thermoset polyimide has a very high glass transitiontemperature (Tg) of approximately 400° C. (as measured by differentialscanning calorimetry (DSC)), and thus excellent dimensional stability atthe processing temperature of other polymers such as polyamides andpolyurethanes commonly used in catheter components. As a result, thepolyimide tube maintains thin-walled, controlled dimensions duringformation and assembly of the catheter, and specifically during hightemperature fusion (i.e., thermal) bonding of the tubular members toform the rapid exchange junction. Thermoplastic polyimide, which has aTg of about 250° C., may also be used, but is less preferred than thehigh glass transition temperature thermoset polyimide.

In one embodiment, the second polymeric material forming the distalportion of the proximal tubular member or the proximal portion of theinner tubular member is selected from the group consisting of polyetherblock amide (PEBAX), nylon, and polyurethane, although a variety ofsuitable polymeric materials different from the first polymeric materialand useful in the formation of catheter shafts can be used. The glasstransition temperature of the second polymeric material forming thedistal portion of the proximal tubular member or the proximal portion ofthe inner tubular member is typically about 30° C. to about 60° C., andmore specifically about 35° C. to about 55° C. Similarly, in oneembodiment, the polymeric material forming a proximal portion of theouter tubular member is selected from the group consisting of PEBAX,nylon, and polyurethane, although a variety of suitable polymericmaterials different from the first polymeric material and useful in theformation of catheter shafts can be used. The distal portion of theproximal tubular member and the proximal portion of the inner tubularmember are preferably formed of compatible materials which are fusionbondable together. In one embodiment, adhesive is not used at the rapidexchange junction to bond the distal portion of the proximal tubularmember and the proximal portion of the inner tubular member together,which are instead fusion bonded together.

The polymeric reinforcing member has sufficient wall thickness toprevent or inhibit the formation of a break in the wall of the tubularmembers defining the inflation lumen and the guidewire lumen at therapid exchange junction. During assembly of the catheter, assemblymandrels or rods (hereafter “assembly rods”), are placed in the lumensof the proximal tubular member and the distal inner tubular member, tokeep the lumens open during fusion of the tubular members to form therapid exchange junction. Heat, and pressure from shrink tubing areapplied to the tubular members to fusion bond the tubular memberstogether and form the rapid exchange junction at the transition betweenthe proximal or an intermediate shaft section and the distal shaftsection at the guidewire proximal port. The polymeric reinforcing memberprevents or inhibits loss of integrity of the inner tubular member andproximal tubular member caused by junction formation as the heatedpolymeric material of the tubular members are flow together duringfusion bonding. Thus, leaks in the guidewire and inflation lumens areprevented or inhibited by the polymeric reinforcing member with a highglass transition temperature.

In one embodiment, a supporting member such as a mandrel is providedwithin at least a section of the inflation lumen, to enhance thecatheter's pushability and crossability. The length and position of thesupport mandrel within the catheter shaft may vary . Typically, thesupport mandrel extends distally from the proximal end of the cathetershaft, or from an intermediate location distal to the proximal end ofthe catheter shaft,. The support mandrel is preferably a solid metal orhigh modulus polymer material, although a variety of differentsupporting members can be used including solid or hollow rods, wires,and the like. In the embodiment having the polymeric reinforcing memberin the inflation lumen, the support mandrel extends adjacent an inner orouter surface of the polymeric reinforcing member, either in contactwith or spaced apart from the surface of the polymeric reinforcingmember. In one embodiment the support mandrel is releasably secured(i.e., not fixedly secured) to the shaft, and is thus free to be removedtherefrom. In an alternative embodiment, the support mandrel distalsection is embedded in polymeric material at or near the rapid exchangejunction. The polymeric reinforcing member prevents or inhibits thesupport mandrel from extending through, and causing a leak in, thetubular members at the rapid exchange junction. In one embodiment, thesupport mandrel is bonded to the polymeric reinforcing member. In oneembodiment, to facilitate bonding the support mandrel to the polymericreinforcing member, the polymeric reinforcing member is a multilayeredtube having a first layer formed of the first polymeric material (e.g.,polyimide), and at least a second layer which is an inner or an outerlayer and which is formed of a different polymeric material, such asPEBAX, nylon, polyurethane or polyolefin hot melt adhesive such asPrimacor (an EAA copolymer), which adheres to metal.

In an alternative embodiment, the balloon catheter has a multilayeredpolymeric sleeve at the rapid exchange intermediate section, with anouter layer formed of a polymer which has a relatively low processingtemperature (i.e., a relatively low glass transition temperature ormelting temperature), and an inner layer. The outer layer facilitatesforming the rapid exchange junction at much lower temperatures than arelikely in the absence of the outer layer, thus preventing or avoidingthinning of the inner layer of the sleeve. The processing temperature isdictated by the glass transition temperature (Tg) for amorphouspolymers, and by the melting temperature (Tm) for semi-crystallinepolymers. The Tg and Tm values of polymers, as measured by DifferentialScanning Calorimetry (DSC)), are commonly known. In one embodiment, theouter layer of the multilayered polymeric sleeve is selected from thegroup consisting of an adhesive polymer such as PRIMACOR (DSC Tm ofabout 90-100° C.), a relatively low durometer polyether block amide(PEBAX) having a hardness of less than about Shore D 55 (DSC Tm of about110-160° C.), nylon 6,3 (DSC Tg of about 150° C.), polyaryl amide (DSCTg of about 85° C.), nylon 6,12 (DSC Tm of about 145-220° C.), and nylon12 (DSC Tm of about 170-185° C.), and the inner layer polymer isselected from the group consisting of a relatively high durometer PEBAX(DSC Tm of about 170° C.), and nylons such as nylon 11 (DSC Tm of about175-195° C.), nylon 6 (DSC Tm of about 190-220° C.), nylon 6,6 (DSC Tmof about 210-270° C.), nylon 6,10 (DSC Tm of about 210-220° C.), nylon6, 12 (DSC Tm of about 145-220° C.), and nylon 4, 6 (DSC Tm of about300° C.), polyphthalamide (DSC Tm of about 145-310° C.), andpolyamide-imide (DSC Tg of about 280° C.).

The balloon catheter of the invention can be configured for a variety ofapplications including coronary angioplasty, peripheral dilatation,stent or graft delivery, drug delivery, and the like. A variety ofsuitable stents can be used with the balloon catheter of invention,which generally comprise expandable tubular members (for details ofstent design, see for example U.S. Pat. No. 5,507,768 (Lau et al.) andU.S. Pat. No. 5,458,615 (Klemm et al.), incorporated by reference hereinin their entireties).

The catheter of the invention maintains the integrity of the inflationlumen and guidewire lumen throughout assembly and use of the catheter,due to the polymeric reinforcing member or multilayered polymericsleeve. The thin-walled polymeric reinforcing member has excellentdimension stability providing a rapid exchange junction having a lowprofile and a suitable stiffness transition between proximal and distalportions of the catheter, to thereby improve handling and performanceand minimize kinking. These and other advantages of the invention willbecome more apparent from the following detailed description andexemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view, partially in section, of a rapid exchangeballoon catheter which embodies features of the invention, having apolymeric reinforcing tube in the inflation lumen in the distal end ofthe proximal tubular member, with a support mandrel having a distalsection extending along an inner surface of the polymeric reinforcingtube.

FIG. 2 is a transverse cross sectional view of the catheter shown inFIG. 1, taken along lines 2-2.

FIG. 3 is a transverse cross sectional view of the catheter shown inFIG. 1, taken along lines 3-3.

FIG. 4 is longitudinal cross section of an alternative rapid exchangejunction which embodies features of the invention, prior to fusing ofthe tubular members together to form the junction during catheterassembly, having a polymeric reinforcing tube in the inflation lumen inthe distal end of the proximal tubular member, with a support mandrelhaving a distal section extending along an outer surface of thepolymeric reinforcing tube.

FIG. 5 is a longitudinal cross section of the rapid exchange junctionshown in FIG. 4, after fusing of the tubular members together to formthe junction.

FIG. 6 is a transverse cross sectional view of the catheter shown inFIG. 5, taken along lines 6-6.

FIG. 7 is a transverse cross sectional view of the catheter shown inFIG. 5, taken along lines 7-7.

FIG. 8 is longitudinal cross section of an alternative rapid exchangejunction which embodies features of the invention, having the polymericreinforcing tube on an outer surface of the proximal portion of theinner tubular member, with a support mandrel in the inflation lumen inthe proximal tubular member.

FIG. 9 is a transverse cross sectional view of the catheter shown inFIG. 8, taken along lines 9-9.

FIG. 10 is a transverse cross sectional view of the catheter shown inFIG. 8, taken along lines 10-10.

FIG. 11 is longitudinal cross section of an alternative rapid exchangejunction which embodies features of the invention, having the polymericreinforcing tube on an inner surface of the proximal portion of theinner tubular member, with a support mandrel in the inflation lumen inthe proximal tubular member.

FIG. 12 is a transverse cross sectional view of the catheter shown inFIG. 11, taken along lines 12-12.

FIG. 13 is a transverse cross sectional view of the catheter shown inFIG. 11, taken along lines 13-13.

FIG. 14 illustrates an alternative aspect of the invention, directed toa balloon catheter having a multilayered sleeve at the rapid exchangeintermediate section.

FIGS. 15 and 16 are transverse cross sectional views of the cathetershown in FIG. 14, taken along lines 15-15 and 16-16, respectively.

FIG. 17 illustrates the balloon catheter of FIG. 14, during formation ofthe rapid exchange intermediate section.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates rapid exchange type balloon catheter 10 embodyingfeatures of the invention. Catheter 10 generally comprises an elongatedcatheter shaft 11 having a proximal end 12, a distal end 13, a proximalshaft section 18 and a distal shaft section 19 at the distal end of theproximal shaft section, and an inflatable balloon 14 on the distal shaftsection. The shaft 11 has an inflation lumen 20, and a guidewirereceiving lumen 21. The proximal shaft section 18 comprises a proximaltubular member 22 defining a proximal portion of the inflation lumen 20,and having a proximal end 23, a distal end 24, and a distal portion 25.In the embodiment illustrated in FIG. 1, the distal end of the proximaltubular member 22 tapers distally to a smaller transverse dimension. Thedistal shaft section 19 comprises an outer tubular member 26 defining adistal portion of the inflation lumen 20, and an inner tubular member 27defining the guidewire lumen 21 in fluid communication with a guidewiredistal port 28 at the distal end of the catheter and a guidewireproximal port 29 at the proximal end of the inner tubular member 27,configured to slidably receive guidewire 40 therein. A rapid exchangejunction at the guidewire proximal port 29 is the transition between thesingle lumen proximal shaft section and the multilumen distal shaftsection. As best illustrated in FIGS. 2 and 3, showing transverse crosssections of the catheter of FIG. 1, taken along lines 2-2 and 3-3,respectively, the outer tubular member 26 is around and joined to boththe inner tubular member 27 and the proximal tubular member 22. Balloon14 has a proximal end sealingly secured to the distal end of outertubular member 26 and a distal end sealingly secured to the distal endof inner tubular member 27, so that its interior is in fluidcommunication with inflation lumen 20. An adapter 41 at the proximal endof the catheter provides access to the inflation lumen 20. The distalend of catheter may be advanced to a desired region of a patient's bodylumen in a conventional manner and balloon 14 inflated to perform aprocedure such a dilate a stenosis, and catheter 10 withdrawn orrepositioned for another procedure.

In the embodiment of FIG. 1, the inner tubular member 27 has a proximalportion 31 in a side-by-side relationship with the distal portion 25 ofthe proximal tubular member 22. The inner tubular member 27 is joined toan inner surface of the outer tubular member 26 and to an outer surfaceof the proximal tubular member 22. Distal to the side-by-side portions25, 31, the inner tubular member 27 transitions to a configuration whichis coaxial with the outer tubular member 26, to define a portion of theguidewire lumen 21 surrounded by the inflation lumen 20, in theembodiment of FIG. 1. However, in an alternative embodiment (not shown),all or part of the length of a distal portion of inner tubular member 27within the inflation lumen 20, located distal to the distal portion 25of the proximal tubular member 22, is joined to the inner surface of theouter tubular member 26 and is not coaxially located therein. Theproximal portion 31 of the inner tubular member 27 is parallel andpreferably fusion bonded to the distal portion 25 of the proximaltubular member 22.

In the embodiment of FIG. 1, a polymeric reinforcing member 32 is atleast in part within the distal portion 25 of the proximal tubularmember 22 on an inner surface thereof. The polymeric reinforcing member32 extends along the length of the distal portion of the proximaltubular member 22 which is fused to the inner tubular member. In theembodiment of FIG. 1, the polymeric reinforcing member 32 has a proximalend located proximal to the distal portion 25 of the proximal tubularmember 22, and a distal end located at the distal end of the proximaltubular member 22. The polymeric reinforcing member 32 is preferablyjoined to the proximal tubular member 22 by thermal fusion process, andthe catheter shaft assembled, according to a method of making a ballooncatheter of the invention. Specifically, the polymeric reinforcingmember 32 is positioned on an inflation lumen shaping assembly rod (notshown), and positioned within the distal end section of the proximaltubular member 22. It should be understood that the proximal tubularmember 22 may be a single tubular member, or alternatively multipletubes joined end to end, so that the polymeric reinforcing member 32 ispositioned within a distal tube of the proximal tubular member 22. Forexample, in the embodiment in which the proximal portion of the proximaltubular member 22 is formed of a polyetherether ketone (PEEK) tubularmember or a metal hypotube, a distal tube such as a polyether blockamide (PEBAX) or nylon tubular member is typically bonded to the distalend of the PEEK or hypotube tubular member, and the polymericreinforcing member 32 placed within the PEBAX or nylon tubular member.The thus combined assembly rod, polymeric reinforcing member 32, andproximal tubular member 22 are then placed in part within the outertubular member 26 and aligned with the inner tubular member 27, to beradially adjacent to the guidewire proximal port 29 area. An assemblyrod (not shown) is positioned in the inner tubular member 27, and thethus assembled rapid exchange junction heated with shrink tubing (notshown) therearound to shrink the shrink tubing and form the thermallyfused junction. The shrink tubing and assembly rods are removed, and areinforcing mandrel 36 is inserted. Due to the high glass transitiontemperature of the polymeric reinforcing member 32, the integrity of theinflation lumen 20 is maintained. The polymeric reinforcing member 32 ofFIG. 1 typically has a length of about 2 to about 10 cm, preferablyabout 5 cm, an outer diameter of about 0.46 to about 0.83 mm, an innerdiameter of about 0.45 to about 0.8 mm, and a wall thickness of about0.01 to about 0.03 mm.

The polymeric reinforcing member 32 is formed of a first polymericmaterial having a glass transition temperature greater than a glasstransition temperature of a second polymeric material forming the distalportion of the proximal tubular member 22 or the proximal portion of theinner tubular member 27. In a presently preferred embodiment, the secondpolymeric material forming the distal portion of the proximal tubularmember 22 or the proximal portion of the inner tubular member 27 isnylon or a copolyamide such as PEBAX. In a presently preferredembodiment, the first polymeric material is thermoset polyimide. Apolyimide reinforcing member 32 is typically formed by a solutionprocess, such as by dip coating a mandrel and removing the mandrel, tothereby produce a tubular member. In a suitable solution formingprocess, a polyimide solution is dip, or otherwise, coated onto aneckable mandrel, as described in U.S. Pat. Nos. 4,826,706 and4,659,622, and the Manufacturing Process section of the Phelps DodgeHigh Performance Conductors brochure, A Primer on Polyimide Tubing, pp.1, incorporated herein by reference in their entireties, and thenseparated intact from the mandrel, to thereby produce a tubular member.The dip coated mandrel can be passed through dies to control the outerdimension of the polyimide reinforcing member 32, and the diameter ofthe removable mandrel determines the inner diameter of the polyimidereinforcing member 32.

In a presently preferred embodiment, the polymeric reinforcing member 32is a solid-walled tube. In one embodiment, the polymeric reinforcingmember 32 consists of a polyimide tube. However, in alternativeembodiments, the polymeric reinforcing member 32 is a multilayered tubehaving a first inner or outer layer formed of the first polymericmaterial (e.g., polyimide), and a second layer on a surface of the firstlayer, the second layer being formed of a third polymeric material (notshown). In a presently preferred embodiment, the third polymericmaterial is the same polymer family as, and compatible with, the secondpolymeric material forming the distal end of the proximal tubular member22. The third polymeric material is typically a polyamide such as nylonor PEBAX, or an adhesive polymer such as the ethylene based adhesivePRIMACOR, providing improved bonding of the polymeric reinforcing member32 to the proximal tubular member 22, or to the inner tubular member 27(see embodiments of FIGS. 8 and 11). Although illustrated as a singlelayer in FIG. 1, the inner tubular member 27 may alternatively comprisea multilayered tubular member, which in one embodiment has an outerlayer formed of the second polymeric material (e.g., nylon or PEBAX).

Support mandrel 36 within the inflation lumen 20 extends from theproximal end 12 of the catheter shaft 11 to the distal end 24 of theproximal tubular member 22 in the embodiment of FIG. 1. The supportmandrel 36 is formed of a material selected from the group consisting ofmetals such as stainless steel and nickel titanium alloy, and highmodulus polymers such as PEEK and nylon, and reinforced compositesthereof, and is preferably formed of stainless steel. The supportmandrel 36 has a distal section extending within the polymericreinforcing member 32 adjacent to the inner surface of the polymericreinforcing member 32, in contact with or alternatively, spaced from theinner surface of the polymeric reinforcing member. The support mandrel36 may be bonded to the polymeric reinforcing member 32 or the proximaltubular member 22 along all or only part of its length, or alternativelyit may be free-floating within the proximal tubular member and/or thepolymeric reinforcing member. In the embodiment of FIG. 1, the supportmandrel 36 is not in contact with the proximal tubular member 22 or withthe polymeric reinforcing member 32 along the length of the supportmandrel 36. Preferably the mandrel is not bonded to the polymericreinforcing member 32. Typically, the polymeric material of the tubularmembers 22, 26, and 27 at the rapid exchange junction, or a separatepolymeric member added therebetween, flows as the tubular members arefused together during catheter assembly, filling space therebetween asfiller 42 (see FIG. 3). In one embodiment, the support mandrel 36 distalend is embedded therein. Thus, in an alternative embodiment (not shown)in which the support mandrel 36 extends beyond the distal end of theproximal tubular member 22 and the polymeric reinforcing member 32, thedistal end of the support mandrel 36 is embedded within shaft polymericmaterial or filler material 42 between the tubular members 22, 27.

FIGS. 4 and 5 illustrate an alternative rapid exchange junctionembodying features of the invention, in which the support mandrel 36extends within the proximal tubular member 22 and adjacent to the outersurface of the polymeric reinforcing member 32 in the proximal tubularmember 22. As best illustrated in FIGS. 6 and 7, showing transversecross sectional views of the catheter of FIG. 5, taken along lines 6-6and 7-7, respectively, the support mandrel extends in the proximaltubular member 22 from the proximal end to the distal end thereof. FIG.4 illustrates the rapid exchange junction of FIG. 5, before the tubularmembers 22, 26 and 27 are fused together during catheter assembly. Thecatheter of FIG. 5 is assembled as outlined above for the embodiment ofFIG. 1, except that an outer surface of the polymeric reinforcing member32 is first bonded to an outer surface of the support mandrel 36 byadhesive bonding, or by fusion bonding to an outer bondable layer of thepolymeric reinforcing member 32. Assembly rods (not shown) are placedwithin the lumens of the inner tubular member 27 and the proximaltubular member 22/polymeric reinforcing member 32 to keep the lumensopen during the application of heat and pressure to fuse the tubularmembers 22, 26 and 27 together. The proximal tubular member 22 is thenpositioned around the support mandrel 36/polymeric reinforcing member 32assembly, and, with an inflation lumen shaping assembly rod positionedin the polymeric reinforcing member and an assembly rod in the innertubular member, shrink tubing around the outer tubular member 26 isheated to fuse the tubular members 22, 26 and 27 together and form therapid exchange junction illustrated in FIG. 5.

FIG. 8 illustrates an alternative rapid exchange junction embodyingfeatures of the invention, in which the polymeric reinforcing member 32is on an outer surface of the proximal portion 31 of the inner tubularmember 27. Support mandrel 36 extends within the proximal tubular member22 from the proximal end to the distal end thereof. FIGS. 9 and 10illustrate transverse cross sectional views of the catheter of FIG. 8,taken along lines 9-9, and 10-10, respectively. As best illustrated inFIG. 10, the distal end of the inflation lumen defined by the distalportion 25 of the proximal tubular member 22 is D-shaped. The D-shapedlumen section results from the shape of the assembly rod positioned inthe proximal tubular member 22 during fusion of the tubular members. Inalternative embodiments, the inflation lumen 20 may have a circular oroval shape. In the embodiment of FIG. 8, the polymeric reinforcingmember 32 has a length approximately equal to the length of the proximalportion 31 of the inner tubular member 27 which is in a side-by-siderelationship with the distal portion of the proximal tubular member 22.Alternatively, the distal end of the polymeric reinforcing member 32 maybe located distal to the distal end of the proximal portion 31 of theinner tubular member 27. Polymeric material or filler 42 (see FIG. 10)typically fills the space within the outer tubular member 26 at therapid exchange junction, between the outer tubular member 26 and theinner tubular member 27/proximal tubular member 22.

FIG. 11 illustrates an alternative rapid exchange junction embodyingfeatures of the invention, in which the polymeric reinforcing member 32is on an inner surface of the proximal portion 31 of the inner tubularmember 27. Support mandrel 36 extends within the proximal tubular member22 from the proximal end to the distal end thereof. FIGS. 12 and 13illustrate transverse cross sectional views of the catheter of FIG. 11,taken along lines 12-12, and 13-13, respectively.

In the illustrated embodiments, the proximal tubular member 22 is asingle tubular member. In an alternative embodiment (not shown), theproximal tubular member 22 comprises a first tube, and a second tubedistal to the first tube and having a proximal end bonded to a distalend of a first tube and forming the distal portion of the proximaltubular member 22. Thus, the proximal tubular member second tube forms amidshaft section, between the proximal first tube and the distal shaftsection. The proximal tubular member first tube is typically formed of amaterial selected from the group consisting of a metal such as stainlesssteel, and a high modulus polymer such as PEEK or nylon, and in apresently preferred embodiment, the second tube is formed at least inpart of the second polymeric material (e.g., nylon or PEBAX), typicallyadhesively bonded to the first tube.

The proximal tubular member 22, inner tubular member 27, and outertubular member 26 of the catheters of the invention may be formed byconventional techniques, e.g. extruding, from materials already founduseful in intravascular catheters such a polyethylene, polyamide,polyesters and composite materials. The use of the support mandrel 36allows the use of otherwise soft materials, such as polyamide blockcopolymers, co-polyesters, nylon and polyurethanes, which are compatiblewith materials used to form dilatation balloons. This facilitates thebonding of the outer 26 and inner 27 tubular members to the balloon 14by conventional techniques, such as laser bonding. The cathetercomponents can be bonded together by heat fusion, adhesive, or by otherconventional means. The polymeric reinforcing member 32 may beadhesively bonded, fusion bonded, or friction fit around or within theinner tubular member or the proximal tubular member, and is preferablysecured thereto by ultraviolet curing adhesive such as is available fromLoctite Corporation.

FIG. 14 illustrates an alternative embodiment of the invention, directedto a balloon catheter 50 having a multilayered sleeve 51 at the rapidexchange intermediate section. Catheter 50 has a proximal shaft sectioncomprising a proximal tubular member 52, a distal shaft sectioncomprising a distal outer tubular member 53 and a distal section of aninner tubular member 54, and an intermediate rapid exchange sectiontherebetween. In the embodiment illustrated in FIG. 14, the intermediatesection is formed by a mid-shaft outer tubular member 55 having aproximal end secured to a distal end of the proximal tubular member 52,and a distal end secured to a proximal end of the distal outer tubularmember 53. In alternative embodiment, a separate mid-shaft outer tubularmember is not provided, and the intermediate rapid-exchange section isformed at least in part by the proximal tubular member 52 and/or thedistal outer tubular member 53. The intermediate section furthercomprises a proximal section of the inner tubular member 54 locatedwithin the mid-shaft outer tubular member 55, having the guidewire lumen56 and a proximal end at a guidewire proximal port 57 in communicationwith a guidewire distal port 58 at the catheter distal end. The innertubular member 54 has a proximal end portion 60 extending through asidewall of the mid-shaft outer tubular member 55, so that the proximalend portion 60 has an outer surface extending along an outer surface ofa portion of the mid-shaft outer tubular member 55. The inflation lumen59 extends within the proximal tubular member 52, the mid-shaft outertubular member 55, and the distal outer tubular member 53 to theinterior of balloon 14 on the distal shaft section. Specifically, in theillustrated embodiment, a portion of the inflation lumen 59 within theintermediate shaft section is formed by the multilayered sleeve 51 andby the space between the inner tubular member 54 and the mid-shaft outertubular member 55. Similarly, the inflation lumen within the distalshaft section is formed by the annular space between the inner tubularmember 54 and the distal outer tubular member 56.

The multilayered sleeve 51 within the mid-shaft outer tubular member 55has a proximal end on a distal end of the proximal tubular member 52,and extends distally from the distal end of the proximal tubular member52 in a side-by-side relation to the proximal end portion 60 of theinner tubular member 54. A portion of the mid-shaft outer tubular member55 separates the inflation lumen 59 from the guidewire lumen 56 at aproximal-most end of the inner tubular member 54. The nature of thepolymers forming the multilayered sleeve is such, as discussed in moredetail below, that the sleeve 51 is preferably a relatively shorttubular member with a proximal end on the distal end of the proximaltubular member 52, and a distal end a relatively short distance distalto the proximal guidewire port 57 within the intermediate shaft section.In the illustrated embodiment, the proximal tubular member 52 has apolymeric jacket 70 thereon with a distal end proximal to themultilayered sleeve 51.

The multilayered sleeve 51 has coextensive outer and inner layers, theouter layer 61 being secured to an inner surface of the mid-shaft outertubular member 55 and the inner layer 62 being secured to an innersurface of the outer layer 61. The multilayered sleeve 51 is preferablyformed by coextruding the layers 61, 62 to form a coextruded tubularmember.

The mid-shaft outer tubular member 55 is formed of a first polymericmaterial, the sleeve outer layer 61 is formed of a second polymericmaterial different than the first polymeric material, and the sleeveinner layer 62 is formed of a third polymeric material which isdifferent than the second polymeric material and which may be the sameas or different than the first polymeric material. The second polymericmaterial (forming sleeve outer layer 61) has a melting temperature orglass transition temperature significantly lower (i.e., at least about20° C. lower) than that of the third polymeric material (forming sleeveinner layer 62) so that during formation of the intermediate shaftsection by melt bonding of the inner tubular member 54 to the mid-shaftouter tubular member 55 at a relatively low temperature the multilayeredsleeve outer layer 61 is melted and/or flows to form filler around theinflation lumen 59 at the guidewire proximal port 57, and themultilayered sleeve inner layer 62 retains a wall integrity around theinflation lumen 59. Typically, the second polymeric material meltingtemperature or glass transition temperature is also significantly lowerthan the first polymeric material (forming mid-shaft outer tubularmember 55), so that the mid-shaft outer tubular member 55 retains a wallintegrity around the inflation lumen 59 at the elevated temperature usedduring melt bonding of the intermediate shaft section tubular members.

Thus, the multilayered sleeve 51 facilitates heat sealing of the tubularmembers to form the rapid exchange intermediate section at a temperaturesignificantly lower than (e.g., at least about 20° F. lower than) anelevated temperature required for a corresponding intermediate sectionhaving a single layered sleeve 51 formed of only the third polymericmaterial (i.e., just layer 62, without layer 61). As a result, as theinner member 54 is compressed against the sleeve 51 during the heatsealing (with mandrels in the guidewire lumen and inflation lumen tokeep the lumens open during the heat sealing), thinning of the innerlayer 62 is prevented or inhibited due to lower heat sealingtemperature.

A variety of suitable materials can be used to form the multilayeredsleeve. Typically, the outer layer 61 is formed of a polymercoextrudable with the polymeric material forming the inner layer 62, andhaving a melting temperature or glass transition temperature which is atleast about 20° C. lower than a melting temperature/glass transitiontemperature of the inner layer 62 polymeric material. Additionally, theouter layer 61 polymeric material is preferably highly bondable to theadjacent polymeric materials. The outer layer 61 is fully encased bysurrounding layers of polymeric material and therefore does not definean exposed outer or inner surface of the catheter shaft. As a result,the polymeric material forming the outer layer 61 need not be alubricious material, and can be selected based on its melting point orglass transition temperature and its bondability. In one embodiment, thepolymeric material forming the outer layer is a relatively nonlubriciousmaterial such as PRIMACOR which is highly bondable to the adjacentpolymers.

The inner layer 62 can be formed of a variety of suitable materialswhich are sufficiently melt bondable to adjacent polymeric materials,including polyamides such as Nylon 12 and Nylon 11, and PEBAX (polyetherblock amide).

In a presently preferred embodiment, the multilayered sleeve 51 consistsof tubing having outer layer 61 of a low melting modified polyolefinsuch as PRIMACOR (ethylene acrylic acid functionalized polyolefin), andan inner layer 62 of Nylon 12 or Nylon 11. PRIMACOR is relatively lowmelting, and is highly melt bondable to adjacent polymeric materialssuch as Nylon and HDPE, and is relatively nonlubricious. PRIMACOR has amelting temperature of about 203° F. (95° C.) and Nylon 12 has a meltingtemperature of about 340° F. (171° C.). Therefore, even at a relativelylow heat sealing temperature of about 400° F. (204° C.) or below, thelow melting outer layer 61 of the multilayered sleeve 51 melts and flowssufficiently to form filler material around the inflation lumen (i.e.,polymeric material which flows into otherwise weakened wall portionsformed as the polymeric tubular members are caused to thin as thetubular members are pressed together during heat bonding), while theNylon 12 of the inner layer 62 maintains much of its wall thickness tomaintain its wall integrity around the inflation lumen. In the absenceof the low melting outer layer 62, a significantly higher temperature ofat least about 420° F. (215° C.) to about 440° F. (227° C.) would berequired to melt and flow a sleeve (located within the mid-shaft outertubular member 55 in place of the multilayered sleeve 51) formed of asingle layer of Nylon 12, sufficiently to form the filler at theintermediate section. However, at that significantly higher heat sealingtemperature, the proximal end of the inner tubular member 54 is forcedinto the melted and flowing polymeric materials of the mid-shaft outertubular member and the sleeve, resulting in an intermediate sectionprone to flexural failure and causing leaks or separation of the tubularmembers with propagation of cracks along the sleeve. As a result, theconfiguration of catheter 50 which facilitates use of the relatively lowheat sealing temperature during assembly of the intermediate section,while still providing a filler material which was caused to melt andflow sufficiently to form filler around the inflation lumen, provides acatheter having an improved intermediate rapid exchange section whichavoids leaks or separation of the tubular members at the high inflationpressures used for an angioplasty or stent deployment procedure.

Thus, the heat sealing temperature used during formation of theintermediate section, and the polymeric materials forming the lowmelting outer layer 61 and the inner layer 62 of the multilayered sleeve51 are selected to allow for formation of an intermediate section whichis not prone to flexural failure. In a presently preferred embodiment,the heat sealing temperature used during formation of the intermediatesection is at least about 110° F. to about 220° F. (40° C. to 100° C.)greater than the melting temperature of the sleeve outer layer 62, butless than or not more than about 50° F. to about 95° F. (10° C. to 35°C.) greater than the melting temperature of the sleeve inner layer 61.In the embodiment having a PRIMACOR outer layer 62 and a Nylon 12 innerlayer 61, the heat sealing temperature is preferably about 390° F. toabout 400° F. (199° C. to 205° C.). The heat sealing temperature is thetemperature applied to an outer surface of the intermediate section byan external heating source such as a heating nozzle or an oven. Theinner layer 62 of the sleeve 51 typically reaches an elevatedtemperature which is somewhat lower than the heat sealing temperature,due to the insulative properties of the surrounding polymers whichinsulate the inner layer somewhat during the heat sealing. Similarly,the outer layer 61 of the multilayered sleeve 51 is insulated somewhatby the surrounding polymer layers including the section of the mid-shaftouter tubular member 55 surrounding the multilayered sleeve andextending between the inflation lumen and guidewire lumen at theproximal portion of the inner tubular member 54. However, the outerlayer 61 is formed of a polymer having a sufficiently low meltingtemperature that the outer layer 61 melts and flows to form fillermaterial during heat sealing as discussed above.

FIGS. 15 and 16 illustrate transverse cross sectional views of thecatheter of FIG. 14, taken along lines 15-15 and 16-16, respectively.The sleeve outer layer 61 is illustrated as substantially retaining itsgenerally annular transverse cross sectional shape in FIGS. 15 and 16.However, it should be understood that sections of the outer layer 61will likely have an unpredictably irregular transverse cross sectionalshape as a result of the low melting material of the outer layer 61melting and flowing to fill in any weakened areas during formation ofthe rapid exchange intermediate section, as discussed above.

FIG. 17 illustrates the catheter of FIG. 14 during formation of therapid exchange intermediate section. The inner tubular member 54 ispositioned within the outer tubular members, with the proximal endportion of the inner tubular member 54 extending through the opening inthe sidewall of the intermediate outer tubular member 55. The tubularmembers are illustrated in FIG. 17 prior to being heated and pressedtogether such that the proximal end portion of the inner tubular memberforces the intermediate outer tubular member 55 against the multilayeredsleeve 51. Heat shrink tubes 80 and 81 positioned around the shaft willradially shrink when heated, to press the tubular members together. Theheat shrink tubes 80, 81 are then removed and discarded after theformation of the rapid exchange intermediate section is completed.Although not illustrated, mandrels would be present in the guidewire andinflation lumens in FIG. 17, to prevent the lumens from collapsingduring bonding of the tubular members.

In the embodiment illustrated in FIGS. 15 and 16 the inner tubularmember 54 is a trilayer multilayered tubular member (the inner tubularmember is shown as a single layer in FIGS. 14 and 17 for ease ofillustration). In one embodiment, the multilayered inner tubular member54 has an inner layer which is compatible with and fusion bondable tothe second polymeric material but which is not compatible with the thirdpolymeric material. Thus, during formation of the rapid exchangejunction, if the outer layers of the multilayered inner tubular member54 flow and thin such that the inner layer of the inner tubular member54 is exposed, the compatibility of the inner tubular member inner layerand the outer layer 61 of the multilayered sleeve 51 will prevent leaksor separation of parts at the rapid exchange junction during use of thecatheter. For example, in one embodiment, the inner layer of the innertubular member 54 is HDPE. HDPE does bond to PRIMACOR, but does notadhere well to Nylon, and as a result, the outer layer 61 of themultilayered sleeve 51 prevents or inhibits failure at the rapidexchange junction.

The catheter shaft will generally have the dimensions of conventionaldilatation or stent delivery catheters. The length of the catheter 10,50, measured from the distal end of the adapter 30 to the distal end ofthe catheter is about 90 to about 150 cm, typically about 137 cm. Theproximal tubular member 22, 52 of the proximal shaft section 18 has alength of about 110 to about 120 cm, typically about 114 cm, an outerdiameter (OD) of about 0.6 to about 1.3 mm, and an inner diameter (ID)of about 0.5 to about 1.1 mm. The outer tubular member 26, 53 of thedistal shaft section 19 has a length of about 25 to about 35 cm,typically about 27 cm, an OD of about 0.76 to about 1.3 mm, and an ID ofabout 0.71 to about 1.2 mm. The inner tubular member 27, 54 of thedistal shaft section 19 has a length of about 25 to about 35 cm,typically about 29 cm, an OD of about 0.5 to about 0.63 mm, and an ID ofabout 0.38 to about 0.5 mm. The inner and outer tubular members 27/26may taper in the distal section to a smaller OD or ID. The diameter ofsupport mandrel 36 may be adjusted as desired to achieve the desiredhandling characteristics, but generally should be about 0.005 to about0.015 inch. The support mandrel 36 length is generally about 110 toabout 125 cm.

The balloon 14 may be formed of a variety of suitable compliant, semi-or non-compliant, or hybrid compliant materials depending on the use ofthe catheter, e.g., dilatation, stent delivery, etc. The length of theballoon 14 is typically about 10 to 50 mm, more specifically about 18 to40 mm. In an expanded state, the balloon diameter is typically about 1.5to about 5 mm, more specifically about 1.5 to about 4 mm. The wallthickness will vary depending on the burst pressure requirements andhoop strength of the balloon material.

While the present invention is described herein in terms of certainpreferred embodiments, those skilled in the art will recognize thatvarious modifications and improvements may be made to the inventionwithout departing from the scope thereof. Moreover, although individualfeatures of one embodiment of the invention may be discussed herein orshown in the drawings of the one embodiment and not in otherembodiments, it should be apparent that individual features of oneembodiment may be combined with one or more features of anotherembodiment or features from a plurality of embodiments.

1-15. (canceled)
 16. A method of making a balloon catheter, comprising:a) assembling a catheter shaft having a proximal tubular member, anouter tubular member formed of a first polymeric material distal to theproximal tubular member, a multilayered sleeve within the outer tubularmember, and an inner tubular member which is within the outer tubularmember and which has a proximal end portion extending out from the outertubular member so that the proximal end portion of the inner tubularmember has an outer surface extending along an outer surface of aportion of the outer tubular member, the multilayered sleeve having anouter layer formed of a second polymeric material and an inner layerformed of a third polymeric material, the second polymeric materialhaving a melting temperature or glass transition temperaturesignificantly lower than a melting temperature or glass transitiontemperature of the first polymeric material and the third polymericmaterial; b) heating and thermally fusing the inner tubular member tothe outer tubular member at a heat sealing temperature which issufficiently greater than the melting temperature or glass transitiontemperature of the second polymeric material so that the secondpolymeric material melts and/or flows to form filler around theinflation lumen, and which is sufficiently low so that the multilayeredsleeve inner layer and the outer tubular member retain wall integrityaround the inflation lumen; and c) bonding a balloon to a distal endsection of the shaft so that the balloon has an interior in fluidcommunication with a lumen in the outer tubular member.